Draft Regulations for the Medicines and Related Substances Act Gazetted for Comment

The long awaited draft General Regulations which will accompany the new Medicines and Related Substances Amendment Act towards mid-year this year, and which will create the legal mechanism to launch the new South African Health Products Regulatory Authority (SAHPRA), were gazetted for comment by the Department of Health on the 27th of January.

The SAHPRA will replace the Medicines Control Council which has existed for over half a century. The SAHPRA will no longer fall directly under the National Department of Health’s control and will become a Section 3(A) public entity in terms of the Public Finance Management Act (Act 1 of 1999).

Section 3(A) Companies are governed by a Board just like any other private listed company, and need to impose licence fees over the economic sectors they regulate in order to recover their operational costs and expansion of their businesses. They are also responsible for all their own legal costs, and can no longer use the State law advisers and attorneys to defend or to prosecute cases they are involved in

As a transitional arrangement the SAHPRA will have to generate 70% of the funds required for its operations (through company licencing and product registration fees), and government will supplement the balance.

The MCC had a limited in-house staff of approximately 100 people up until 2015 and has relied on various expert committees under the MCC Council and part-time experts from academic institutions, including medical doctors, pharmacists, pharmacologists, veterinarians, agriculturalists, and lawyers to do its job mandated by the Medicines Act. It will now have to attract experts from the private and academic sector as permanent employees.

According to the current MCC Registrar of Medicines, the MCC hired 52 new staff members over the last two years and intends employing a further 30 staff members when the SAHPRA is established. This will bring the staff complement to just over 180 full-time members.

The MCC has a massive historical medicine registration backlog and the pace of assessing medicines for registration has become a major crisis for both the pharmaceutical and complementary medicine industry. It currently receives between 1,200 and 1,600 new product applications a year.

Complaints from the pharmaceutical industry and even patient organisations compelled previous Health Minister Manto Tshabalala Msimang to launch an investigation into the workings of the MCC in 2006, which revealed in 2008 that the reasons for the registration backlogs are related to poor infrastructure, insufficiently trained staff, high staff turnover and lack of financial resources. Little has changed in the last ten years, and the queue of products waiting to be authorised for sale is getting longer.

The MCC has an estimated backlog of 1,200 novel medicines (new chemical entities), 2,900 generic medicines, 9,500 grandfathered medicines which have never been assessed for their safety or effectiveness and yet allowed to be sold (going all the way back to the 1970’s), and an additional 120,000 complementary medicines and health supplements on record requiring registration applications to be in by the end of 2019.

That’s potentially 133,000 products awaiting assessment for their safety, quality and efficacy. In that last 50 years of medicines registration, it is estimated that only 13,000 medicines were fully assessed and registered.

In April last year, the MCC published a list of six (6) complementary medicines in the government gazette which have been given the ‘right of sale’, pending their further assessment towards registration. To date, none of these six products have been registered and the MCC is remaining tight lipped over their application status, or how many other applications they have received since 2014 when the registration of complementary medicines begun.

Currently the MCC can only register approximately 120 new medicines a year. Despite intending to increase the SAHPRA workforce by 30 staff, the current registration backlogs will take generations clear.

When the SAHPRA is established it will also have the added burden of assessing and registering thousands of medical devices which have never been registered before, as well as all skincare products containing ‘scheduled substances’. We already know that the Medicines Control Council intends all natural health product ingredients will be scheduled, even if at Schedule 1. There are potentially thousands of natural and synthetic skincare products which may have to meet strict registration criteria as medicines in the near future.

THE DEFINITION OF A COMPLEMENTARY MEDICINE HAS CHANGED ONCE AGAIN

It seems the Medicines Control Council can’t settle on a legal definition for ‘complementary medicine’.

Already we have seen five different definitions in government gazettes since 2002. Once again the Medicines Control Council is making the erroneous inclusion of the ‘complementary medicine’ definition in the sub-legislation (regulations) instead of the principal Act itself.

Complementary medicines and health supplements are NOT pharmaceutical drugs which were defined in the Medicines Act fifty years ago without amendment. They are a totally new class of health products, requiring their own definition in the Act. The MCC cannot legislate by regulation!

The new ‘complementary medicine’ definition in the draft General Regulations reads:

Health Supplements are a sub-category of ‘complementary medicine’ and are defined as follows:

From the proposed definition above, ALL natural health products will be deemed complementary medicines, or the new sub-category termed ‘health supplements’. All these definitions are excessively broad and may even include foods used to stay healthy and promote wellness.

By deleting the previous references to complementary used by the disciplines of the Allied Health Professions Council of South Africa, and replacing it with any disciplines determined by the Authority (SAHPRA) in future, manufactured African Traditional Medicines will be ensnared into the definition of complementary medicines. The SAHPRA, in consultation with the Minister, may even declare skin products or super foods containing natural ingredients ‘complementary medicines’, if they are ‘purported’ to have health-giving properties.